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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03303482
Other study ID # UW17246
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 19, 2017
Est. completion date May 21, 2018

Study information

Verified date November 2018
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background. To increase school readiness, Pre-K programs for low-income children must be responsive to the role of trauma in the lives of children, families, and staff. In 2017-2018, the School District of Philadelphia's (SDP) Office of Early Childhood Education will help Pre-K teachers support children's social‐emotional and behavioral health, which is essential for early learning, by offering teachers a professional development course called Enhancing Trauma Awareness (ETA).

Purpose. To determine whether teachers who take ETA will have: 1) better work functioning; 2) more trusting work relationships; and 3) better health.

Population. Pre-K classroom teachers (n=128) working in centers under SDP auspice that serve exclusively low-income (≤300 % of poverty) children.

Intervention. A 12-week professional development course—Enhancing Trauma Awareness—will delivered by Lakeside Global Institute in 6 group sessions, with 16 teachers per group and each session lasting 2.5 hours.

Design. Consenting teachers will be randomly assigned by classroom (lead teacher and/or assistant teacher) to receive the ETA course in either fall 2017 (intervention groups) or spring 2018 (wait-list control groups).

Data collection and analysis. An external evaluation team (Temple University) will administer a confidential, online survey to all 128 teachers in fall 2017 (before fall course), winter 2017 (after fall course), and spring 2018 (after spring course). Teacher-children relationship quality will be the a priori primary outcome, and secondary outcomes will be assessed across the domains of work functioning, trust, and health.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date May 21, 2018
Est. primary completion date May 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:Preschool classroom teacher who works in a center that is under the auspice of the School District of Philadelphia and serves exclusively low-income (=300 % of poverty) children.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhancing Trauma Awareness (Diane Wagenhals, MEd—Lakeside Global Institute)
The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.

Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
Temple University Lakeside Global Institute, North Wales, PA, USA, The School District of Philadelphia, United Way of Greater Philadelphia and Southern New Jersey (UWGPSNJ)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in teacher-children relationship quality (specifically, levels of perceived conflict) at 3 months A modified version of the Student-Teacher Relationship Scale (STRS) conflict subscale will be used to allow each teacher to provide one global or aggregated assessment of her/his relationships with all the children in the classroom. The conflict subscale includes eight items to assess negative, insecure, and hostile aspects of relationships. The teacher-children relationship quality measurement will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in mindfulness (Cognitive and Affective Mindfulness Scale-Revised) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in empathy (Interpersonal Reactivity Index) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in emotion regulation (Emotion Regulation Questionnaire) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in compassion satisfaction (Professional Quality of Life Scale) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in job satisfaction (adapted from Gallup Well-Being Work Index) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in attitudes about trauma-informed care (Attitudes Related to Trauma-Informed Care Scale) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in burnout (Maslach Burnout Inventory General) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in trust in relationships with parents, supervisors, and other staff members (adapted from Trust in Schools Instruments) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in mentally and physically unhealthy days (CDC Health-Related Quality of Life Healthy Days Core Module) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
Secondary Change in quality and duration of nighttime sleep (Pittsburgh Sleep Quality Index) at 3 months The measure will be assessed for all 128 teachers through online surveys at baseline (before the fall course) and at 3 months (after the fall course).
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